Following 2 pilot studies showing positive effects with either a single session (de Mello et al. 1996) or multiple sessions (de Mello et al. 2002) of exercise training, de Mello and colleagues conducted a prospective controlled trial comparing the effect of 30 days of initial L-dopa or placebo treatment versus 45 days of three/week 30 minute aerobic arm ergometry exercise training sessions in reducing the incidence of periodic limb movements during sleep (de Mello et al. 2004). Participants were all male, with complete chronic paraplegia (AISA A, lesion levels between T7-T12) with participants crossing over from 1 treatment to the next. The incidence of periodic limb movements was determined with polysomnographic analysis conducted as part of a sleep study and the effect of each treatment was noted relative to a baseline period. There was a 15 day washout period between the drug and exercise treatments to limit any carry-over effects. Both treatments were equally effective in reducing the amount of periodic limb movements such that the authors suggested a physical activity intervention as the first line of treatment and treatment with dopaminergic agonists to be reserved for persons who prove refractory to the exercise approach (De Mello et al. 2004).
There is level 2 evidence from a single study and support from two additional pre-post trials that a 45 day period of 3/week 30 minute aerobic exercise sessions (arm cycle ergometry) is equally effective as L-dopa in reducing night-time periodic limb movements in persons with complete paraplegia.